An Open Therapeutic Project to Confirm the Efficacy Tolerability and Safety Profile of Lantus in Everyday Medical Practice

Phase 4

Completed

• Conditions: Diabetes Mellitus
• Interventions: Drug: INSULIN GLARGINE

• Registration Number: NCT00576368
• Lead Sponsor: Sanofi

Brief Summary

The objective of this survey on this registered product is to confirm the efficacy, and safety profile of Lantus in every day medical practice. This program will also help to obtain information about the use of the insulin titration regimen and handling of the Lantus insulin analogue.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-06
• Study Completion: 2004-04
• Status Verified: 2007-12
• Study First Submitted: 2007-12-17
• Study First Submitted QC: 2007-12-17
• Study First Posted: 2007-12-19
• Last Update Submitted: 2007-12-28
• Last Update Posted: 2008-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4464

Inclusion Criteria

• All newly diagnosed diabetics and existing diabetics uncontrolled on other anti-diabetic therapy, where treatment with basal insulin is required to control hyperglycaemia, and who the treating investigator considers may benefit from the treatment with Lantus, could enter in this program.

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	INSULIN GLARGINE	-

Primary Outcome Measures

Name	Time	Method
Glycemic status (Fasting Blood Glucose, Fasting Plasma Glucose, and HbA1C as done in routine medical practice)	at least 3months

Trial Locations

Locations (1)

Sanofi-Aventis; 🇧🇪 Brussels, Belgium